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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lenses, Soft Contact, Daily Wear
510(k) Number K982988
Device Name PRECISION UV (VASURFILCON A)
Applicant
Wesley Jessen Corp.
333 E. Howard Ave.
Des Plaines,  IL  60018
Applicant Contact JOSEPH FOOS
Correspondent
Wesley Jessen Corp.
333 E. Howard Ave.
Des Plaines,  IL  60018
Correspondent Contact JOSEPH FOOS
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received08/26/1998
Decision Date 01/06/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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